Transapical mitral valve repair device

ABSTRACT

Methods and devices for repairing a cardiac valve. A minimally invasive procedure includes creating an access in the apex region of the heart through which one or more instruments may be inserted. The device can implant artificial heart valve chordae tendineae into cardiac valve leaflet tissues to restore proper leaflet function and prevent reperfusion. The device punctures the apex of the heart and travels through the ventricle. The tip of the device rests on the defective valve and punctures the valve leaflet. A suture or a suture/guide wire combination is inserted, securing the top of the leaflet to the apex of the heart. A resilient element or shock absorber mechanism adjacent to the outside of the apex of the heart minimizes the linear travel of the device in response to the beating of the heart or opening/closing of the valve.

RELATED APPLICATIONS

This application is a continuation of and claims priority toInternational Application No: PCT/US2012/043761, filed Jun. 22, 2012,entitled “Transapical Mitral Valve Repair Device,” which claims priorityto and the benefit of U.S. Provisional Application No. 61/501,404, filedJun. 27, 2011, entitled “Transapical Mitral Repair with Pre-FormedKnot,” and U.S. Provisional Application No. 61/550,772, filed Oct. 24,2011, entitled “Transapical Mitral Valve Repair Device,” the disclosuresof which are incorporated herein by reference in their entirety.

BACKGROUND

1. Field of the Disclosure

The disclosure herein relates to methods and devices for performingcardiac valve repairs, and more particularly, the disclosure relates tomethods and devices for performing minimally invasive mitral ortricuspid valve repairs using of PTFE neochords through a minimallyinvasive incision, while the heart is beating.

2. Description of the Background

As illustrated in FIG. 1, the human heart 10 has four chambers, whichinclude two upper chambers denoted as atria 12, 16 and two lowerchambers denoted as ventricles 14, 18. A septum 20 divides the heart 10and separates the left atrium 12 and left ventricle 14 from the rightatrium 16 and right ventricle 18. The heart further contains four valves22, 24, 26, and 28. The valves function to maintain the pressure andunidirectional flow of blood through the body and to prevent blood fromleaking back into a chamber from which it has been pumped.

Two valves separate the atria 12, 16 from the ventricles 14, 18, denotedas atrioventricular valves. The left atrioventricular valve, the mitralvalve 22, controls the passage of oxygenated blood from the left atrium12 to the left ventricle 14. A second valve, the aortic valve 24,separates the left ventricle 14 from the aortic artery (aorta) 30, whichdelivers oxygenated blood via the circulation to the entire body. Theaortic valve 24 and mitral valve 22 are part of the “left” heart, whichcontrols the flow of oxygen-rich blood from the lungs to the body. Theright atrioventricular valve, the tricuspid valve 26, controls passageof deoxygenated blood into the right ventricle 18. A fourth valve, thepulmonary valve 28, separates the right ventricle 18 from the pulmonaryartery 32. The right ventricle 18 pumps deoxygenated blood through thepulmonary artery 32 to the lungs wherein the blood is oxygenated andthen delivered to the left atrium 12 via the pulmonary vein.Accordingly, the tricuspid valve 26 and pulmonic valve 28 are part ofthe “right” heart, which control the flow of oxygen-depleted blood fromthe body to the lungs.

Both the left and right ventricles 14, 18 constitute “pumping” chambers.The aortic valve 24 and pulmonic valve 28 lie between a pumping chamber(ventricle) and a major artery and control the flow of blood out of theventricles and into the circulation. The aortic valve 24 and pulmonicvalve 28 have three cusps, or leaflets, that open and close and therebyfunction to prevent blood from leaking back into the ventricles afterbeing ejected into the lungs or aorta 30 for circulation.

Both the left and right atria 12, 16 are “receiving” chambers. Themitral valve 22 and tricuspid valve 26, therefore, lie between areceiving chamber (atrium) and a ventricle so as to control the flow ofblood from the atria to the ventricles and prevent blood from leakingback into the atrium during ejection into the ventricle. Both the mitralvalve 22 and tricuspid valve 26 include two or more cusps, or leaflets(shown in FIG. 2), that are encircled by a variably dense fibrous ringof tissues known as the annulus. The valves are anchored to the walls ofthe ventricles by chordae tendineae (chordae) 42. The chordae tendineae42 are cord-like tendons that connect the papillary muscles 44 to theleaflets (not shown) of the mitral valve 22 and tricuspid valve 26 ofthe heart 10. The papillary muscles 44 are located at the base of thechordae 42 and are within the walls of the ventricles. They serve tolimit the movements of the mitral valve 22 and tricuspid valve 26 andprevent them from being reverted. The papillary muscles 44 do not openor close the valves of the heart, which close passively in response topressure gradients; rather, the papillary muscles 44 brace the valvesagainst the high pressure needed to circulate the blood throughout thebody. Together, the papillary muscles 44 and the chordae tendineae 42are known as the subvalvular apparatus. The function of the subvalvularapparatus is to keep the valves from prolapsing into the atria when theyclose.

As illustrated with reference to FIG. 2, the mitral valve 22 includestwo leaflets, the anterior leaflet 52 and the posterior leaflet 54, anda diaphanous incomplete ring around the valve, called the annulus 60.The mitral valve 22 has two papillary muscles 44, the anteromedial andthe posterolateral papillary muscles, which attach the leaflets 52, 54to the walls of the left ventricle 14 via the chordae tendineae 42. Thetricuspid valve 26 typically is made up of three leaflets with threepapillary muscles. However, the number of leaflets can range between twoand four. The three leaflets of the tricuspid valve 26 are referred toas the anterior, posterior, and septal leaflets. Although both theaortic and pulmonary valves each have three leaflets (or cusps), they donot have chordae tendineae.

Various disease processes can impair the proper functioning of one ormore of the valves of the heart. These disease processes includedegenerative processes (e.g., Barlow's Disease, fibroelasticdeficiency), inflammatory processes (e.g., Rheumatic Heart Disease), andinfectious processes (e.g., endocarditis). Additionally, damage to theventricle from prior heart attacks (i.e., myocardial infarctionsecondary to coronary artery disease) or other heart diseases (e.g.,cardiomyopathy) can distort the valve's geometry causing it todysfunction. However, the vast majority of patients undergoing valvesurgery, such as mitral valve surgery, suffer from a degenerativedisease that causes a malfunction in a leaflet of the valve, whichresults in prolapse and regurgitation.

Generally, a heart valve may malfunction two different ways. Onepossible malfunction, valve stenosis, occurs when a valve does not opencompletely and thereby causes an obstruction of blood flow. Typically,stenosis results from buildup of calcified material on the leaflets ofthe valves causing them to thicken and thereby impairing their abilityto fully open and permit adequate forward blood flow.

Another possible malfunction, valve regurgitation, occurs when theleaflets of the valve do not close completely thereby causing blood toleak back into the prior chamber. There are three mechanisms by which avalve becomes regurgitant or incompetent; they include Carpentier's typeI, type II and type III malfunctions. A Carpentier type I malfunctioninvolves the dilation of the annulus such that normally functioningleaflets are distracted from each other and fail to form a tight seal(i.e., do not coapt properly). Included in a type I mechanismmalfunction are perforations of the valve leaflets, as in endocarditis.A Carpentier's type II malfunction involves prolapse of one or bothleaflets above the plane of coaptation. This is the most common cause ofmitral regurgitation, and is often caused by the stretching or rupturingof chordae tendineae normally connected to the leaflet. A Carpentier'stype III malfunction involves restriction of the motion of one or moreleaflets such that the leaflets are abnormally constrained below thelevel of the plane of the annulus. Leaflet restriction can be caused byrheumatic disease (IIIa) or dilation of the ventricle (IIIb).

FIG. 3 illustrates a prolapsed mitral valve 22. As can be seen withreference to FIG. 3, prolapse occurs when a leaflet 52, 54 of the mitralvalve 22 is displaced into the left atrium 12 during systole. Becauseone or more of the leaflets 52, 54 malfunction, the mitral valve 22 doesnot close properly, and, therefore, the leaflets fail to coapt. Thisfailure to coapt causes a gap 63 between the leaflets 52, 54 that allowsblood to flow back into the left atrium 12, during systole, while it isbeing ejected into the left ventricle 14. As set forth above, there areseveral different ways a leaflet may malfunction, which can thereby leadto regurgitation.

Although stenosis or regurgitation can affect any valve, stenosis ispredominantly found to affect either the aortic valve 24 or the pulmonicvalve 28, whereas regurgitation predominately affects either the mitralvalve 22 or the tricuspid valve 26. Both valve stenosis and valveregurgitation increase the workload on the heart 10 and may lead to veryserious conditions if left un-treated; such as endocarditis, congestiveheart failure, permanent heart damage, cardiac arrest, and ultimatelydeath. Since the left heart is primarily responsible for circulating theflow of blood throughout the body, malfunction of the mitral valve 22 ortricuspid valve 26 is particularly problematic and often lifethreatening. Accordingly, because of the substantially higher pressureson the left side of the heart, left-sided valve dysfunction is much moreproblematic.

Malfunctioning valves may either be repaired or replaced. Repairtypically involves the preservation and correction of the patient's ownvalve. Replacement typically involves replacing the patient'smalfunctioning valve with a biological or mechanical substitute.Typically, the aortic valve 24 and pulmonic valve 28 are more prone tostenosis. Because stenotic damage sustained by the leaflets isirreversible, the most conventional treatment for stenotic aortic andpulmonic valves is removal and replacement of the diseased valve. Themitral valve 22 and tricuspid valve 26, on the other hand, are moreprone to deformation. Deformation of the leaflets, as described above,prevents the valves from closing properly and allows for regurgitationor back flow from the ventricle into the atrium, which results invalvular insufficiency. Deformations in the structure or shape of themitral valve 22 or tricuspid valve 26 are often repairable.

Valve repair is preferable to valve replacement. Bioprosthetic valveshave limited durability. Moreover, prosthetic valves rarely function aswell as the patient's own valves. Additionally, there is an increasedrate of survival and a decreased mortality rate and incidence ofendocarditis for repair procedures. Further, because of the risk ofthromboembolism, mechanical valves often require further maintenance,such as the lifelong treatment with blood thinners and anticoagulants.Therefore, an improperly functioning mitral valve 22 or tricuspid valve26 is ideally repaired, rather than replaced. However, because of thecomplex and technical demands of the repair procedures, the overallrepair rate in the United States is only around 50%.

Conventional techniques for repairing a cardiac valve arelabor-intensive, technically challenging, and require a great deal ofhand-to-eye coordination. They are, therefore, very challenging toperform, and require a great deal of experience and extremely goodjudgment. For instance, the procedures for repairing regurgitatingleaflets may require resection of the prolapsed segment and insertion ofan annuplasty ring so as to reform the annulus of the valve.Additionally, leaflet sparing procedures for correcting regurgitationare just as labor-intensive and technically challenging, if notrequiring an even greater level of hand-to-eye coordination. Theseprocedures involve the implantation of sutures (e.g., ePTFE or GORE-TEX™sutures) so as to form artificial chordae in the valve. In theseprocedures, rather than performing a resection of the leaflets and/orimplanting an annuplasty ring into the patient's valve, the prolapsedsegment of the leaflet is re-suspended using artificial chord sutures.Oftentimes, leaflet resection, annuplasty, and neochord implantationprocedures are performed in conjunction with one another.

Regardless of whether a replacement or repair procedure is beingperformed, conventional approaches for replacing or repairing cardiacvalves are typically invasive open-heart surgical procedures, such assternotomy or thoracotomy, that require opening up of the thoraciccavity so as to gain access to the heart. Once the chest has beenopened, the heart is bypassed and stopped. Cardiopulmonary bypass istypically established by inserting cannulae into the superior andinferior vena cavae (for venous drainage) and the ascending aorta (forarterial perfusion), and connecting the cannulae to a heart-lungmachine, which functions to oxygenate the venous blood and pump it intothe arterial circulation, thereby bypassing the heart. Oncecardiopulmonary bypass has been achieved, cardiac standstill isestablished by clamping the aorta and delivering a “cardioplegia”solution into the aortic root and then into the coronary circulation,which stops the heart from beating. Once cardiac standstill has beenachieved, the surgical procedure may be performed. These procedures,however, adversely affect almost all of the organ systems of the bodyand may lead to complications, such as strokes, myocardial “stunning” ordamage, respiratory failure, kidney failure, bleeding, generalizedinflammation, and death. The risk of these complications is directlyrelated to the amount of time the heart is stopped (“cross-clamp time”)and the amount of time the subject is on the heart-lung machine (“pumptime”).

Furthermore, the conventional methods currently being practiced for theimplantation of the artificial chordae are particularly problematic.Because the conventional approach requires the heart to be stopped(e.g., via atriotomy) it is difficult to accurately determine, assess,and secure the appropriate chordal length. Since the valve will notfunction properly if the length of the artificial chordae is too long ortoo short, the very problem sought to be eradicated by the chordalreplacement procedure may, in fact, be exacerbated. Using conventionaltechniques, it is very difficult to ensure that the chordae are of thecorrect length and are appropriately spaced inside the ventricle toproduce a competent valve.

There is a significant need to perform mitral valve repairs using lessinvasive procedures while the heart is still beating. Accordingly, thereis a continuing need for new procedures and devices for performingcardiac valve repairs, such as mitral and tricuspid valve repairs, whichare less invasive, do not require cardiac arrest, and are lesslabor-intensive and technically challenging. Chordal replacementprocedures and artificial chordae that ensure the appropriate chordallength and spacing so as to produce a competent valve are of particularinterest. The methods and repair devices presented herein meet theseneeds.

SUMMARY

It is an object of the disclosure to provide a method and device toenable minimally invasive, beating-heart, mitral valve repair.

It is another object of the disclosure to provide an expansile elementthat can be inserted through a mitral valve leaflet, and which can bedeployed above the valve leaflet in order to secure it in place.

It is another object of the disclosure to enable chordal replacementwith ePTFE. A related object of the present disclosure is to provide achordal replacement that facilitates mitral valve repair.

Another object of the disclosure is to provide a method and device fortransapical mitral valve repair that uses a small incision. A relatedobject of the disclosure is to provide a method that does not require aSternotomy. Another related object of the disclosure is to provide amethod that does not require cardiopulmonary bypass or aorticmanipulation.

Another object of the disclosure is to provide a method and device fortransapical mitral valve repair that uses real-time, echo-guided,chordal length adjustment.

A basic concept of the method of the disclosure herein is to insert atool via the apex of the heart, grasp or pierce the defective heartvalve leaflet, deploy a PTFE neochord, and adjust the length of thechord under echo guidance to resolve the mitral valve regurgitation.

These and other objects of the present disclosure are accomplished byproviding a device for minimally invasive repair of a defective heartvalve while the heart is beating. The heart can be accessed through theapex or a point lateral/near to the apex with a small-diameter shaftedinstrument. The instrument might be a needle or a catheter. Usingultrasound guidance (real-time transesophagael echocardiography), theshafted instrument is inserted through an access port at the apex (ornear the apex) and the instrument is guided to make contact with themitral valve leaflet at the location where the operator has decided thata neochord should be inserted. Typically, this would be the body of theanterior or posterior leaflet in a location where the valve hasprolapsed as a result of a broken or elongated chord. The instrumentpunctures the apex of the heart and travels through the ventricle. Thetip of the instrument rests on the defective valve and punctures thevalve leaflet. The instrument then inserts either a suture or asuture/guide wire combination, securing the top of the leaflet to theapex of the heart with an artificial chordae. A resilient element orshock absorber mechanism adjacent to the outside of the apex of theheart minimizes the linear travel of the instrument in response to thebeating of the heart or opening/closing of the valve.

In a first embodiment, the instrument punctures the defective leaflettwice. A first needle deploys a loop wire with the loop encircling thearea immediately above a second needle. The second needle deploys asuture through the loop deployed by the first needle. After the loopensnares the suture, the loop and suture are retracted into the firstneedle. The instrument is pulled out of the heart while the sutureremains through the leaflet. The length of the suture is adjusted andthe ends of the suture are then affixed to the outer surface of theheart near the apex of the heart. Typically, the suture would be securedto a pledget.

According to another embodiment, once the instrument is in contact withthe mitral valve leaflet in the targeted location, a “PTFE-wrappedneedle” is advanced rapidly across the leaflet and subsequently rapidlywithdrawn. After the PTFE-wrapped needle is advanced across the leaflet,the core is withdrawn and a pusher needle/sheath remains across theneedle. Withdrawal pressure is applied to the two ends of the PTFEsuture at the base of the needle (outside of the heart). This withdrawalpressure results in the development of a pre-formed knot that attains asignificant size in the atrium, above the leaflet. The pusher needle isthen withdrawn with the delivery instrument, and the length of the PTFEsutures are adjusted so that the amount of mitral regurgitation isminimized. Once this length is determined, the PTFE is secured to theouter surface of the heart using a pledget.

In another embodiment, a single needle punctures the defective leafletand deploys a coated, coiled guide wire having a suture woven throughit. The suture is then pulled, causing the guide wire to configure intoa predetermined shape above the leaflet. The instrument is thenretracted out of the heart and the length of the guide wire/suture isadjusted. Once this length is determined, the guide wire/suture isaffixed near the apex of the heart.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other features, aspects, and advantages of the presentdisclosure are considered in more detail, in relation to the followingdescription of embodiments thereof shown in the accompanying drawings,in which:

FIG. 1 is a cut-away anterior view of the human heart showing theinternal chambers, valves, and adjacent structures.

FIG. 2 is a perspective view of a healthy mitral valve with the leafletsclosed.

FIG. 3 is a top view of a dysfunctional mitral valve with a visible gapbetween the leaflets.

FIG. 4 shows a simplified view of a heart with four chambers and apexregion.

FIG. 5 illustrates the advancement of a device through an accessedregion of the heart in accordance with the methods of embodimentsherein.

FIGS. 6 a-6 c illustrate an exemplary device according to embodimentsherein.

FIG. 7 illustrates an exemplary device according to embodiments herein.

FIGS. 8 a-8 f show exemplary stages of the tip portion of an instrumentaccording to an embodiment herein.

FIGS. 9 a-9 d show an exemplary instrument according to anotherembodiment herein.

FIGS. 10 a-10 e illustrate an additional embodiment herein.

FIG. 11 shows an exemplary instrument according to an embodiment herein.

FIGS. 12 a-12 g show an exemplary instrument according to anotherembodiment herein.

FIGS. 13 a-13 c illustrates formation of a bulk knot in accordance withan embodiment herein.

FIGS. 14 a-14 c show an additional embodiment herein.

FIG. 15 illustrates an installed chord in accordance with an embodimentherein.

FIG. 16 illustrates an expansile element according to another embodimentherein.

FIG. 17 is another illustration of an expansile element according toembodiments herein.

FIG. 18 illustrates use of a single needle device in accordance with themethods of embodiments herein.

FIG. 19 illustrates use of an alternate single needle device inaccordance with the methods of embodiments herein.

FIG. 20 shows an additional embodiment herein.

FIG. 21 illustrates locking steps in accordance with the methods ofembodiments herein.

FIG. 22 illustrates use of the device of embodiments herein inaccordance with another method.

DETAILED DESCRIPTION

In accordance with the methods of embodiments herein, the heart may beaccessed through one or more openings made by a small incision(s) in aportion of the body proximal to the thoracic cavity, for instance, inbetween one or more of the ribs of the rib cage, proximate to thexyphoid appendage, or via the abdomen and diaphragm. Access to thethoracic cavity may be sought so as to allow the insertion and use ofone or more thorascopic instruments, while access to the abdomen may besought so as to allow the insertion and use of one or more laparoscopicinstruments. Insertion of one or more visualizing instruments may thenbe followed by transdiaphragmatic access to the heart. Additionally,access to the heart may be gained by direct puncture (i.e., via anappropriately sized needle, for instance an 18 gauge needle) of theheart from the xyphoid region. Access may also be achieved usingpercutaneous means. Accordingly, the one or more incisions should bemade in such a manner as to provide an appropriate surgical field andaccess site to the heart. See for instance, Full-Spectrum CardiacSurgery Through a Minimal Incision Mini-Stemotomy (Lower Half) TechniqueDoty et al. Annals of Thoracic Surgery 1998; 65(2): 573-7 andTransxiphoid Approach Without Median Stemotomy for the Repair of AtrialSeptal Defects, Barbero-Marcial et al. Annals of Thoracic Surgery 1998;65(3): 771-4 which are specifically incorporated in their entiretyherein by reference.

After prepping and placing the subject under anesthesia atransesophageal echocardiogram (TEE) (2D or 3D), a transthoracicechocardiogram (TTE), intracardiac echo (ICE), or cardio-optic directvisualization (e.g., via infrared vision from the tip of a 7.5 Fcatheter) may be performed to assess the heart and its valves. A carefulassessment of the location and type of dysfunction on the TEE, TTE, orother such instrument, facilitates the planning of the appropriatesurgical procedure to be performed. The use of TEE, TTE, ICE, or thelike, can assist in determining if there is a need for adjunctiveprocedures to be performed on the leaflets and subvalvular apparatus andcan indicate whether a minimally invasive approach is advisable.

Once a minimally invasive approach is determined to be advisable, one ormore incisions are made proximate to the thoracic cavity so as toprovide a surgical field of access. The total number and length of theincisions to be made depend on the number and types of the instrumentsto be used as well as the procedure(s) to be performed. The incision(s)should be made in such a manner so as to be minimally invasive. By“minimally invasive” is meant in a manner by which an interior organ ortissue may be accessed with as little as possible damage being done tothe anatomical structure through which entry is sought. Typically, aminimally invasive procedure is one that involves accessing a bodycavity by a small incision made in the skin of the body. By “smallincision” is meant that the length of the incision generally should beabout 1 cm to about 10 cm, or about 4 cm to about 8 cm, or about 7 cm inlength. The incision may be vertical, horizontal, or slightly curved. Ifthe incision is placed along one or more ribs, it should follow theoutline of the rib. The opening should extend deep enough to allowaccess to the thoracic cavity between the ribs or under the sternum andis preferably set close to the rib cage and/or diaphragm, dependent onthe entry point chosen.

One or more other incisions may be made proximate to the thoracic cavityto accommodate insertion of a surgical scope. Such an incision istypically about 1 cm to about 10 cm, or about 3 cm to 7 cm, or about 5cm in length and should be placed near the pericardium so as to allowready access to and visualization of the heart. The surgical scope maybe any type of endoscope, but is typically a thorascope or laparoscope,dependent upon the type of access and scope to be used. The scopegenerally has a flexible housing and at least a 16-times magnification.Insertion of the scope through an incision allows a practitioner toanalyze and “inventory” the thoracic cavity and the heart so as todetermine further the clinical status of the subject and plan theprocedure. For example, a visual inspection of the thoracic cavity mayreveal important functional and physical characteristics of the heart,and will indicate the access space (and volume) required at the surgicalsite and in the surgical field in order to perform the reparativecardiac valve procedure. At this point, the practitioner can confirmthat access of one or more cardiac valves through the apex of the heartis appropriate for the particular procedure to be performed.

With reference to FIG. 4, once a suitable entry point has beenestablished, a suitable device such as one described herein, may beadvanced into the body in a manner so as to make contact with the heart10. The advancement of the device may be performed in conjunction withsonography or direct visualization (e.g., direct transbloodvisualization). For instance, the device may be advanced in conjunctionwith TEE guidance or ICE so as to facilitate and direct the movement andproper positioning of the device for contacting the appropriate apicalregion of the heart. Typical procedures for use of echo guidance are setforth in Suematsu, Y., J. Thorac. Cardiovasc. Surg. 2005; 130:1348-1356,herein incorporated by reference in its entirety.

One or more chambers 12, 14, 16, 18 in the heart 10 may be accessed inaccordance with the methods disclosed herein. Access into a chamber inthe heart may be made at any suitable site of entry but is preferablymade in the apex region of the heart (e.g., at or adjacent to the apex72). Typically, access into the left ventricle 14, for instance, toperform a mitral valve repair, is gained through making a small incisioninto the apical region, close to (or slightly skewed toward the left of)the median axis 74 of the heart 10. Typically, access into the rightventricle 18, for instance, to perform a tricuspid valve repair, isgained through making a small incision into the apical region, close toor slightly skewed toward the right of the median axis 74 of the heart10. Generally, an apex region of the heart is a bottom region of theheart that is within the left or right ventricular region but is distalto the mitral valve 22 and tricuspid valve 26 and toward the tip or apex72 of the heart 10. More specifically, an “apex region” of the heart iswithin a few centimeters to the right or to the left of the septum 20 ofthe heart 10. Accordingly, the ventricle can be accessed directly viathe apex 72, or via an off apex location that is in the apical region,but slightly removed from the apex 72, such as via a lateral ventricularwall, a region between the apex and the base of a papillary muscle, oreven directly at the base of a papillary muscle. Typically, the incisionmade to access the appropriate ventricle of the heart is no longer thanabout 1 mm to about 5 cm, from 2.5 mm to about 2.5 cm, from about 5 mmto about 1 cm in length.

As explained above, both the mitral valve 22 and tricuspid valve 26 canbe divided into three parts—an annulus, leaflets, and a sub-valvularapparatus. If the valve is functioning properly, when closed, the freemargins of the leaflets come together and form a tight junction the arcof which, in the mitral valve, is known as the line of coaptation. Thenormal mitral and tricuspid valves open when the ventricles relaxallowing blood from the left atrium to fill the decompressed ventricle.When the ventricle contracts, the increase in pressure within theventricle causes the valve to close, thereby preventing blood fromleaking into the atrium and assuring that all of the blood leaving theventricle is ejected through the aortic valve 24 and pulmonic valve 28into the arteries of the body. Accordingly, proper function of thevalves depends on a complex interplay between the annulus, leaflets, andsubvalvular apparatus. Lesions in any of these components can cause thevalve to dysfunction and thereby lead to valve regurgitation. As setforth above, regurgitation occurs when the leaflets do not coapt at peakcontraction pressures. As a result, an undesired back flow of blood fromthe ventricle into the atrium occurs.

Once the malfunctioning cardiac valve has been assessed and the sourceof the malfunction verified, a corrective procedure can be performed.Various procedures can be performed in accordance with the methods ofthe disclosure herein in order to effectuate a cardiac valve repair,which will depend on the specific abnormality and the tissues involved.

In one embodiment, a method of the present disclosure includes theimplantation of one or more artificial chordae tendineae into one ormore leaflets of a malfunctioning mitral valve 22 and/or tricuspid valve26. It is to be noted that, although the following procedures aredescribed with reference to repairing a cardiac mitral or tricuspidvalve by the implantation of one or more artificial chordae, the methodsherein presented are readily adaptable for various types of leafletrepair procedures well-known and practiced in the art, for instance, anAlfieri procedure. In general, the methods herein will be described withreference to a mitral valve 22.

As illustrated in FIG. 5, in accordance with the methods of the presentdisclosure, once an appropriate incision has been made in the apexregion of the heart, for instance, in the apex 72, a suitable instrument75 is then introduced into the ventricle 14 of the heart and advanced insuch a manner so as to contact one or more cardiac tissues (forinstance, a leaflet, an annulus, a cord, a papillary muscle, or thelike) that are in need of repair. Sonic guidance, for instance, TEEguidance or ICE, may be used to assist in the advancement of the deviceinto the ventricle and the grasping of the cardiac tissue with thedevice. Direct trans-blood visualization may also be used.

A suitable instrument 75, such as the one presented in FIGS. 5, 6 a-6 c,and 7, will typically include an elongate member 78 with a functionaldistal portion 81 having a tip 84 configured for repairing a cardiacvalve tissue, for instance, a mitral valve leaflet 52, 54. Thefunctional distal portion 81 of the device is configured for performingone or more selected functions, such as grasping, suctioning,irrigating, cutting, suturing, or otherwise engaging a cardiac tissue.Using a manipulatable handle portion 87, the instrument 75 is thenmanipulated in such a manner so that a selected cardiac tissue (forinstance, a papillary muscle, one or more leaflet tissues, chordaetendineae, or the like) is contacted with the functional distal portion81 of the instrument 75 and a repair effectuated, for instance, a mitralor tricuspid valve repair.

In one embodiment, the instrument 75 is designed to extend and contractwith the beat of the heart. During systolic contraction, the median axis74 of the heart 10 shortens. The distance from the apex 72 of the heart(where the device is inserted) to the mitral leaflet 52, 54 varies by1-2 cm with each heartbeat. Accordingly, the instrument 75 is designedsuch that the tip 84 of the device (i.e. the part that contacts themitral leaflet 52, 54) is “floating” wherein each systole is associatedwith approximately 1-2 cm of outward extension of the device. Referringto FIGS. 6 a-6 c, the instrument 75 includes an inner tube 89 and anouter tube 91. The inner tube 89 is configured to slide within the outertube 91. A handle 87 is attached to the outer tube 91. A resilientelement 94, such as a spring is present so that, as the outer tube 91 isadvanced and the tip 84 makes contact with the leaflet 52, 54, theelongate portion 78, being connected to the inner tube 89, pushesagainst the resilient element 94. With forward pressure predetermined bythe resilient element 94, once the tip 84 comes in contact with theleaflet 52, 54, even though the user continues to advance the instrument75, the amount of pressure applied by the tip to the leaflet 52, 54 willremain constant as a result of the presence of the resilient element 94.The resilient element 94 allows a defined, constant forward force on theleaflet 52, 54. A user may feel contact, but will also be able toconfirm visually that the resilient element 94 is extending andcontracting.

While a smaller seating surface enables the tip 84 to be more easilylocalized, it may be more likely to perforate the leaflet. A largerseating surface is more likely to remain in the selected location, butis harder to land on the leaflet 52, 54. Accordingly, in someembodiments, the delivery system may have a blunt end, to avoid pushingthe entire device through the leaflet; to that end, a device with anexpandable balloon 88 at the distal end, such as shown in FIG. 7, may beprovided.

The inflatable balloon 88 is provided at the tip 84. The balloon 88 candistribute pressure more widely on the underside of the leaflet 52, 54,and minimize the likelihood that the leaflet will be perforatedunintentionally by the device. Such a balloon 88 can be configured tosurround the tip 84, thereby providing a broader seating surface againstthe leaflet. Once the instrument 75 is inserted, the balloon 88 can beinflated using methods known in the art. For example, the instrument 75may include an inner lumen 90 comprising annealed stainless steelsurrounded by an outer tube 92 made of urethane or other flexiblematerial. A clearance space 93 between the inner lumen 90 and the outertube 92 provides an inflation lumen. The outer tube should be bonded atone end around the tip 84 and at the other end to a valve 95, such as aTouhy valve. The valve 95 is tightened to the inner lumen 90. Aninflation port 98 is provided to enable inflation of the balloon 88. Insome embodiments, the balloon 88 may provide an expanded seating surfaceof approximately 6-7 mm.

Preferably, characteristics of the end surface of the tip 84 includeease of location on the leaflet, tendency to remain in one location,does not harm the leaflet by penetration, and can serve as a platform todeploy one or more needles, as described below.

FIGS. 8 a-8 f show exemplary stages of the tip portion 84 of aninstrument 75 according to an embodiment of the present disclosure. Inthe embodiment illustrated in FIGS. 8 a-8 f, the tip 84 has twochannels; each channel contains a needle. Preferably, one channelcontains a larger needle, such as a 20-gauge and the other channelcontains a smaller needle. It is not necessary that the needles bedifferent sizes, nor is the needle gauge particular to the practice ofthis disclosure; other sizes may be used. In some embodiments, the snaredescribed below could be a smaller gauge than the suture, allowing theneedles to be the same size. Preferably, the two needles are as farapart as possible in the tip 84, so as to make the resulting suture thatis installed less likely to tear the leaflet. In FIG. 8 a, the needlesare retracted. In FIG. 8 b, both needles puncture the mitral valveleaflet (not shown); first the snare needle 151, then the suture needle154. As shown in FIG. 8 c, a metal (steel, nitinol, or other material)snare 157 is advanced through the larger needle. The snare 157 isadapted so that the loop can be selectively retracted or extended withinthe larger needle. The snare 157 is further adapted so that once itemerges (on the atrial side of the leaflet), it will deform in apredetermined manner, such as approximately a 90-degree bend, and is inposition to capture a PTFE suture. While these steps may occur in rapidsequence, the snare 157 should not emerge until both needles havepunctured the mitral valve leaflet. Preferably, the snare 157 includes adirectional handle so that it is always deployed toward the center ofthe tip 84. FIG. 8 d shows a PTFE suture 160 that is injected throughthe smaller needle (21 or 22 gauge) and passes through the deployedsnare 157. Preferably, heparinized saline is used to inject the PTFEsuture 160. As shown in FIG. 8 e, the snare 157 is withdrawn into the20-gauge needle, capturing the PTFE suture 160. In FIG. 8 f, the deviceis removed, leaving a PTFE suture in the leaflet. An alternate approachwould be to advance a metal guide wire through the smaller needle, graspit, and pull it back. The PTFE suture could then be tied to the guidewire and pulled through.

FIG. 9 illustrates another embodiment using a “between the leaflets”approach for grasping and attaching a suture to a mitral valve leaflet52, 54. In this embodiment, a shafted instrument 100 is inserted betweentwo mitral valve leaflets 52, 54, as shown in FIG. 9 a. FIG. 9 b shows asnare 103 and a stiff “upper stabilizer” 106 deployed at the end of theinstrument 100. Preferably, the snare 103 extends at approximately a90-degree angle from the shaft 109. Typically, the upper stabilizer 106will have an angle of approximately 70-80° from the shaft. A user thenpulls the instrument 100 back until the upper stabilizer 106 lands onthe mitral leaflet 52. Essentially, the leaflet 52 is stabilized by theshaft 109 (on the leading edge of the leaflet) and the snare stabilizer106. Next, as shown in FIG. 9 c, a second stabilizer (a narrow snare orprong) 112 is deployed below the leaflet 52. Typically, the secondstabilizer 112 will have an angle of approximately 50-60° from theshaft. The second stabilizer 112 is progressively advanced toward theupper stabilizer 106. The leaflet 52 is “grabbed” by the two stabilizers106, 112. Once the leaflet 52 is grasped, as shown in FIG. 9 d, a needle115 is ejected at an angle from the shaft 109. The needle 115 penetratesthe leaflet 52, and passes through the upper stabilizer 106 and thesnare 103. A PTFE suture is then injected through the needle 115 andcaptured by the snare 103. The needle 115 can then be retracted whilethe snare 103 holds the suture. Next, the snare 103 is withdrawn withthe suture penetrating through the leaflet 52. The lower stabilizer 112is withdrawn, followed by the upper stabilizer 106.

Another embodiment is shown in FIG. 10. A slotted needle 165 is wrappedwith a PTFE suture. The needle 165 can be as small as 22 gauge. In someembodiments, the needle 165 may be electropolished to make it smooth.Referring to FIG. 10 a, a suture 168 is prepared on the needle 165.Preferably, the suture is made of PTFE material. One end of the suture168 emerges from a distal end 171 of the needle 165, and another endemerges from a slot 172. The suture 168 may have a simple knot 173 (seeFIG. 12) where it emerges from the distal end 171 of the needle 165 andanother knot at the end of the wrapping near the slot 172. In someembodiments, small, temporary silicone rings (not shown) may be used tohold the suture 168 at the distal and proximal ends. As shown in FIG. 10b, a first coil 175 is wound from the outside toward the inside (top tobottom). The suture 168 should wrapped tightly around the needle 165 forapproximately 20-200 turns. Other numbers of turns may be used. As shownin FIG. 10 c, a second coil 176 is wound from the outside toward theinside (bottom to top). Again, the suture 168 should be wrapped tightlyaround the needle 165 for approximately 20-200 turns. Other numbers ofturns may be used. A short section may be left in the center forthreading and completing the rest of the knot. The ends of the suture168 may be crossed and looped from the end of the distal coil in thedistal direction or in the direction of the proximal coil. The knot canbe tightened by sliding the two coils 175, 176 to the center andtwisting the coils to take up the slack in the needle slot, as shown inFIG. 10 e. In some embodiments, a medical grade silicone may be used onthe needle 165 and the wrapped suture 168 to allow smooth withdrawal ofthe needle 165 during subsequent procedure. FIG. 11 shows a finishedversion of a needle 165 with a suture 168 wrapped thereon.

Referring to FIG. 12, and particularly the portion labeled (a), theneedle 165 has a suture 168 tightly wrapped around one end thereof. Apusher 177 or hollow guide wire may be provided on the needle 165. Asshown in FIG. 12 b, the wrapped needle 165 is inserted into the hearttoward the mitral valve leaflet 52. The wrapped needle 165 can beadvanced across the mitral valve leaflet 52 until the end of thewrapping, indicated by 179, is in the atrium above the leaflet 52, asshown in FIG. 9 c, leaving a small hole. In FIG. 9 d, the needle 165 iswithdrawn, but the pusher 177 and suture 168 remain. In FIG. 9 e, awithdrawal force applied to the ends of the suture 168 resulting in thetransformation of the tightly wrapped coil of the suture 168 into abulky knot 180 as shown in FIG. 9 f. Lastly, as shown in FIG. 9 g, thepusher 177 is withdrawn, leaving the permanent bulky knot 180, whichanchors the suture 168 to the leaflet 52. In this embodiment, theresulting implant is made solely of a PTFE suture, which is atime-tested means of fixing the mitral valve.

There are many possible configurations of PTFE material and needle toform the bulky knot 180. For example, the suture 168 may form two ormore loops, such as a figure 8. In some embodiments, the suture 168 maybe double wrapped on the needle 165. Alternatively, the needle 165 maybe non-hollow; that is, a solid needle. FIG. 13 illustrates how thesimple bulky knot 180, described above, is formed. In FIG. 13 a, thesuture 168 is deployed. In FIG. 13 b, the withdrawal force applied tothe ends of the suture 168 pulls the knot 173 toward the end of thewrapping 174. Once the two ends meet, the bulky knot 180 remains, asshown in FIG. 13 c.

In other words, according to the “bulky knot” concept: a PTFE suture 168(or any kind of suture, or perhaps even a “filament”) is wrapped tightlyaround a small-gauge needle 165, near the tip. The needle 165 is thenadvanced through the valve leaflet 52. A “pusher” 177 surrounds theneedle 165 and extends to the level of the “wrap” of suture/filament.Once the sharp point end of the needle and the wrap/coil ofsuture/filament 179 has passed through the leaflet 52, the needle 165 iswithdrawn. This leaves the coil (s) 175, 176 unsupported. Tension on theends of the filament/suture 168 at the base of the needle then cause abulky knot 180 to form. Finally, the pusher 177 is pulled back, leavinga bulky knot 180 on the “far” side of the leaflet 52.

FIG. 14 illustrates an alternate embodiment of the bulky knot describedabove. An additional bulky knot 182 is created below the leaflet 52. Theadditional bulky knot 182 will sandwich the leaflet 52 between twoknots. The distance between the knots should be no more than thethickness of the leaflet 52. As shown in FIG. 14 b, a spacer 185 may beprovided between the bulky knots 180, 182.

Referring to FIG. 15, once one or more bulky knots 180 have beenimplanted to one or more cardiac tissues, lengthening or shortening ofthe artificial chordae can be performed by knotting, tying, cutting,anchoring, and otherwise manipulating the cords in a manner so as toachieve the desired (e.g., optimal) length. Once the optimal length ofthe neochord is determined, the suture 168 can be tied off and/oranchored, outside of the apex 72, by any means well known in the art,for instance, by tying one or more knots into the suture 168. One ormore pledgets 143 may also be used.

According to embodiments herein, the bulky knot concept can be used foran Alfieri stitch; that is, an Alfieri stitch can be created bysequentially deploying a double helix knot on first one leaflet of themitral valve (i.e., the anterior leaflet 52), followed by the posteriorleaflet 54, then tying the two together, using a knot pusher deployedfrom the apex 72.

Furthermore, while the embodiments disclosed herein are described withreference to a heart valve leaflet. The concepts are equally applicableto penetrating and applying similar knots to the annulus 60 of thevalves. In some embodiments, several bulky knots 180 may be installed inthe annulus 60 and tied together.

FIG. 16 shows another embodiment in which an expansile element 121 hasbeen created. One approach for the expansile element 121 is a standardguide wire 125 made of an elongated spring formed of steel, nitinol, orother material. The guide wire 125 may be coated with PTFE or otherappropriate coating. Alternatively, the guide wire 125 may remainuncoated. The guide wire 125 should be appropriately sized, such as 0.9mm. Other sizes may be used. The expansile element 121 includes a suture128 in the core. Preferably, the suture 128 is made of PTFE. The suture128 is woven through the guide wire 125 as illustrated in FIG. 16 sothat pulling on the suture 128 causes deformation of the tip of theexpansile element 121 into a figure of 8 (or similar) configuration.FIG. 17 shows the progression of the expansile element 121 from aninactivated form as shown in FIG. 17 a to a partially activated form inFIG. 17 b, then to a fully activated form in FIG. 17 c. The fullyactivated form may be in a spiral or helical shape or have one, two,three, or more loops, as desired.

Using an expansile element 121, a single-needle puncture procedure canbe performed. As shown in FIG. 18, a neochord implant 131 that containsan expansile element 121 on the tip can be deployed once it has passedthrough the leaflet 52. The neochord implant 131 is inside anappropriately sized needle 134. The needle 134 may be 20-gauge,19-gauge, 18-gauge, or other appropriate size. The needle 134 is used topenetrate the leaflet 52 and is then withdrawn, leaving the neochordimplant 131 in place. The expansile element 121 is activated by pullingon the suture 128 causing deformation of the expansile element 121 atthe tip into a predetermined configuration such as shown at 136, whichkeeps the implant 131 in place.

In some embodiments, the expansile element 121 may be self-forming; thatis, the expansile element 121 can be made of a pre-shaped “memory” metalthat is inserted into the needle 134. Withdrawal of the needle 134allows the expansile element 121 to form its required shape.

Alternatively, as shown in FIG. 19, an appropriately sized needle 137 orfine wire may be located inside the neochord implant 131. As above, theneedle 137 is used to penetrate the leaflet 52 and is then withdrawn,leaving the neochord implant 131 in place. An advantage of having theneedle 137 inside the implant 131 is that it enables tighter tolerancebetween the implant 131 and the leaflet 52. Additionally, if a fine wireis used, it could also be used to activate the expansile element 121instead of the suture 128.

FIG. 20 shows an alternate configuration for the expansile element 121.An additional loop 140 is created below the leaflet 52. The additionalloop 140 will sandwich the leaflet 52 between two loops of the implant131. The distance between the loops should be no more than the thickesta leaflet 52 could be. As the additional loop 140 is formed, it willconform to the thickness of the leaflet 52.

Referring to FIG. 21, once one or more implants 131 have been implantedto one or more cardiac tissues, the implantation device is removedthrough the access (e.g., via the access port), and the tail ends of thesuture(s) 128 are trailed therethrough. Artificial chordae lengtheningor shortening can be performed by knotting, tying, cutting, anchoring,and otherwise manipulating the cords in a manner so as to achieve thedesired (e.g., optimal) length. Once the optimal length of the neochordis determined, the suture 128 can be tied off and/or anchored, outsideof the apex 72, by any means well known in the art, for instance, bytying one or more knots into the suture 128. One or more pledgets 143may also be used.

In another approach, the neochord implant 131 of the present disclosureherein can be used in an edge-to-edge (Alfieri) repair, as shown in FIG.22. A first implant 131 is deployed on one leaflet 52. A second implant131 is deployed on the second leaflet 54. The two implants are thenbanded together to create adjoining edges.

The sutures that are to be implanted (for instance, so as to function asartificial chordae tenidinae or neochords) may be fabricated from anysuitable material, such as but not limited to: polytetrafluoroethylene(PTFE), nylon, Gore-Tex, Silicone, Dacron, or the like. With respect tothe implantation of artificial chordae, the particular function of thereplacement cord is dependent upon the configuration, physicalcharacteristics and relative positioning of the structure(s). In certainembodiments, the structures act to restrain the abnormal motion of atleast a portion of one or more of the valve leaflets. In otherembodiments, the prosthetic chordae provide a remodeling as well as aleaflet restraint function where the latter may address latent orresidual billowing of the leaflet body and/or latent or residualprolapsing of the leaflet edge, either of which may result from theremodeling itself or from a physiological defect.

It is to be noted that a fundamental challenge in successfully replacingone or more chordae tendineae and restoring proper functioning of acardiac valve, is determining the appropriate artificial cord length andsecuring the artificial cord at a location so as to ensure the optimalreplacement chordae length. The valve will not function properly if thelength of the artificial cord is too long or too short. Because theheart is stopped using conventional techniques, it is virtuallyimpossible to ensure that the cords are of the correct length and areappropriately spaced inside the ventricle to produce a competent valve.Accordingly, methods of the disclosure herein include the measuring anddetermining of the optimal arrangement, length, placement, andconfiguration of an implanted suture, for instance, a replacement cordlength, while the heart is still beating and, typically, before theaccess site of the heart is closed. An optimal arrangement of a suture,for instance, an optimal cord length, is that arrangement that effectssaid repair, for instance, by minimizing reperfusion as determined bymeans well known in the art, for instance, by direct echo guidance.

Therefore, in accordance with the methods of the disclosure herein, onceone or more artificial chordae have been implanted to one or morecardiac tissues, the implantation device is removed through the access(e.g., via the access port), and as stated above, the tail ends of thesuture(s) are trailed therethrough. The optimal length of the implantedsuture(s) (i.e., neochord) can then be determined by manipulating theends of the suture(s) in a graded and calibrated fashion that is akin tomanipulating a marionette. The manipulation of the artificial chordaemay be done in conjunction with audio or visual assistance means, forinstance, direct echo (e.g., echocardiographic) guidance, by which thedegree and extent of regurgitation can be measured while the chordallength is being manipulated, so as to determine a chordal length thatminimizes any observed regurgitation. Since, in a preferred embodiment,the heart is still beating the degree of cardiac regurgitation can beevaluated real time and the optimal neochord(s) length determined.Accordingly, an optimal cord length is a cord length that is determined,for instance, by direct echo guidance, to minimize or at least reducecardiac valve regurgitation. Artificial chordae lengthening orshortening can be performed, as described above, by knotting, tying,cutting, anchoring, and otherwise manipulating the cords in a manner soas to achieve the desired (e.g., optimal) length. Once the optimallength of the neochord is determined, the sutures can be tied off and/oranchored, outside of the apex, by any means well known in the art, forinstance, by tying one or more knots into the suture. One or morepledgets may also be used.

Once the corrective procedures are completed, the repaired valve may befurther assessed, and if the repair is deemed satisfactory, the one ormore devices (e.g., cannulae, sheath, manifold, access port, etc.) areremoved, the access closed, as described above, and the percutaneousincisions are closed in a fashion consistent with other cardiac surgicalprocedures. For instance, one or more purse-string sutures may beimplanted at the access site of the heart and/or other access sites, soas to close the openings.

It is further contemplated that the devices and methods disclosed hereincan be used in procedures outside the heart. That is, while theembodiments have been described with reference to a heart valve, thedevices and methods described above may be used in any procedure thatrequires penetrating a tissue and forming a knot on the far sidethereof.

The present disclosure has been described with references to specificembodiments. While particular values, relationships, materials and stepshave been set forth for purposes of describing concepts of thedisclosure herein, it will be appreciated by persons skilled in the artthat numerous variations and/or modifications may be made to thedisclosure herein as shown in the disclosed embodiments withoutdeparting from the spirit or scope of the basic concepts and operatingprinciples of the disclosure herein as broadly described. It should berecognized that, in the light of the above teachings, those skilled inthe art could modify those specifics without departing from thedisclosure herein taught herein. Having now fully set forth certainembodiments and modifications of the concept underlying the presentdisclosure herein, various other embodiments as well as potentialvariations and modifications of the embodiments shown and describedherein will obviously occur to those skilled in the art upon becomingfamiliar with such underlying concept. It is intended to include allsuch modifications, alternatives and other embodiments insofar as theycome within the scope of the appended claims or equivalents thereof. Itshould be understood, therefore, that the disclosure herein might bepracticed otherwise than as specifically set forth herein. Consequently,the present embodiments are to be considered in all respects asillustrative and not restrictive.

1. A method comprising: introducing into a ventricle of a heartproximate to a heart valve leaflet a suture having a distal portion anda proximal portion; piercing the leaflet from a ventricular side of theleaflet to an atrial side of the leaflet to form an opening in theleaflet; passing through the opening from the ventricular side to theatrial side the distal portion of the suture disposed in a firstconfiguration, and with the proximal portion of the suture remaining onthe ventricular side of the leaflet; and causing the distal portion ofthe suture to change from the first configuration to a secondconfiguration, the second configuration being larger than the opening inthe leaflet.
 2. The method of claim 1, further comprising fixing theproximal portion of the suture to the heart.
 3. The method of claim 1,wherein: the distal portion of the suture is formed as a coil having aplurality of turns; in the first configuration, the coil is straight;and in the second configuration, the coil is a loop.
 4. The method ofclaim 1, wherein: the introducing includes introducing into theventricle a needle having a distal portion and having the distal portionof the suture disposed about an exterior of the distal portion of theneedle in the first configuration; the piercing includes passing adistal tip of the needle through the leaflet; the passing includepassing the distal portion of the needle and the distal portion of thesuture through the leaflet; and the second configuration of the sutureis a bulky knot.
 5. The method of claim 1, wherein: the introducingincludes introducing into the ventricle a tubular pusher having a distalend and a needle slidably disposed in the pusher and having a distalportion with the distal portion of the suture wrapped around the distalportion of the needle in the first configuration, the distal portion ofthe needle and the distal portion of the suture extending from thedistal end of the pusher; the causing includes withdrawing the distalportion of the needle into the distal end of the pusher.
 6. The methodof claim 1, wherein the valve leaflet is a first leaflet of the heartvalve and the suture is a first suture, further comprising: introducinginto the ventricle proximate to the heart valve a second suture having adistal portion and a proximal portion; piercing a second leaflet of theheart valve from a ventricular side of the second leaflet to form anopening in the second leaflet; passing through the opening in the secondleaflet from the ventricular side to the atrial side the distal portionof the second suture disposed in a first configuration, and with theproximal portion of the second suture remaining on the ventricular sideof the second leaflet; causing the distal portion of the second sutureto change from the first configuration to a second configuration, thesecond configuration being larger than the opening in the secondleaflet; and joining the first suture and the second suture in theventricle proximate to the heart valve.
 7. The method of claim 1,wherein: the suture includes a medial portion between the distal portionand the proximal portion; and the passing includes the medial portion ofthe suture disposed in a first configuration remaining on theventricular side of the leaflet, and further comprising causing themedial portion of the suture to change from the first configuration to asecond configuration, the second configuration being larger than theopening in the leaflet, a portion of the leaflet being disposed betweenthe medial portion of the suture in the second configuration and thedistal portion of the suture in the second configuration.
 8. The methodof claim 1, wherein the causing includes withdrawing proximally theproximal portion of the suture.
 9. An apparatus comprising: a tubularpusher having a distal end and an interior diameter; a needle having adistal portion, the needle slidably disposed within the pusher with thedistal portion of the needle extending from the distal end of thepusher; a suture having a first section and a second section, the firstsection having a first portion disposed in the pusher and a secondportion including a coil formed of multiple turns about an exterior ofthe needle, the coil having a proximal end and a distal end, and furtherhaving an external diameter larger than the internal diameter of thepusher, the second portion having a first end at the distal end of thecoil, the second section having a second portion with a first endcoupled to the first end of the second portion of the first section,extending proximally from the first end of the second portion of thefirst section through the interior of the coil to the proximal end ofthe coil, and including a loop forming segment extending distally from afirst end of the loop forming segment at the proximal end of the coilalong the outside of the coil to the distal end of the coil, andextending proximally through the interior of the coil to the proximalend of the coil at a second end of the loop forming segment, and havinga first portion extending proximally from the second end of the loopforming segment into the pusher, wherein the suture is configured forthe coil to be formed into a loop by (1) withdrawing the needleproximally through the coil and the pusher to separate the coil from theneedle, and (2) withdrawing the first portion of the second sectionrelative to the distal end of the pusher to draw the second end of theloop forming segment of the second portion of the second sectionproximally from the proximal end of the coil to draw the proximal end ofthe coil and the distal end of the coil towards each other.
 10. Theapparatus of claim 9, wherein the coil is a first coil, the loop is afirst loop, and the second portion of the second section includes asecond coil formed of multiple turns about the exterior of the needleproximal to the first coil and having a proximal end and a distal end,the second portion of the second section extending proximally from thefirst end of the second portion through the interior of the second coilto the proximal end of the second coil, the first end of the loopforming segment of the second portion of the second section extendingfrom the distal end of the second coil, the second portion of the firstsection having a loop forming segment extending from a first end of theloop forming segment proximally from the proximal end of the first coilalong the outside of the second coil to the proximal end of the secondcoil and extending distally through the interior of the second coil tothe distal end of the second coil at a second end of the loop formingsegment of the second portion of the first section, the first portion ofthe first section extending proximally from the second end of the loopforming segment of the second portion of the first section into thepusher, wherein the suture is configured for the second coil to beformed into a second loop by (1) withdrawing the needle proximallythrough the second coil and the pusher to separate the second coil fromthe needle, and (2) withdrawing the first portion of the first sectionrelative to the distal end of the pusher to draw the second end of theloop forming segment of the second portion of the first sectionproximally from the distal end of the second coil to draw the proximalend of the second coil and the distal end of the second coil towardseach other.
 11. The apparatus of claim 9, wherein: the needle has aninterior lumen and the distal portion of the needle has a slotcommunicating with the lumen; the first portion of the first section ofthe suture and the first portion of the second section of the sutureextend through the lumen of the needle; the slot extends through thecoil; and the second portion of the second section of the suture extendsthrough the interior of the coil within the lumen and extends throughthe slot from the lumen to the exterior of the coil.
 12. The apparatusof claim 10, wherein: the needle has an interior lumen and the distalportion of the needle has a slot communicating with the lumen; the firstportion of the first section of the suture and the first portion of thesecond section of the suture extend through the lumen of the needle; theslot extends through the first coil and the second coil; the secondportion of the second section of the suture extends through the interiorof the first coil within the lumen and extends through the slot from thelumen to the exterior of the first coil; and the second portion of thefirst section of the suture extends through the interior of the secondcoil within the lumen and extends through the slot from the lumen to theexterior of the second coil.
 13. The apparatus of claim 9, wherein thedistal end of the pusher has an external diameter and the loop has adimension larger than the external diameter of the pusher.
 14. Theapparatus of claim 9, further comprising an outer tube surrounding atleast a portion of the pusher, the outer tube having a distal end withan external diameter greater than an external diameter of the pusher,the distal end of the outer tube being spaced proximally from the distalend of the pusher.
 15. The apparatus of claim 14, wherein the outer tubeincludes an expandable balloon, the distal end of the outer tube definedby the expandable balloon.
 16. The apparatus of claim 9, furthercomprising a device operably coupled to a proximal portion of theneedle, the device configured to withdraw the needle proximally relativeto the distal end of the pusher.
 17. An apparatus, comprising: a suturehaving a first section and a second section, the first section having afirst portion and a second portion, the second portion of the firstsection including a coil formed of multiple turns, the coil having afirst end and a second end, the second portion of the first sectionhaving a first end at the second end of the coil, the first portion ofthe first section extending away from the first end of the coil, thesecond section having a second portion with a first end coupled to thefirst end of the second portion of the first section, extending from thefirst end of the second portion of the first section through theinterior of the coil to the first end of the coil, and including a loopforming segment extending from a first end of the loop forming segmentat the first end of the coil along the outside of the coil to the secondend of the coil, and extending through the interior of the coil to thefirst end of the coil at a second end of the loop forming segment, andhaving a first portion extending away from the second end of the loopforming segment, the loop forming segment holding the coil in a loopedconfiguration with the first end of the coil adjacent the second end ofthe coil.
 18. The apparatus of claim 17, wherein the coil is a firstcoil, the loop forming segment is a first loop forming segment, and thesecond portion of the second section includes a second coil formed ofmultiple turns, the second coil having a first end and a second end, thesecond portion of the second section extending from the first end of thesecond portion of the second section through the interior of the secondcoil to the first end of the second coil, the second portion of thefirst section having a second loop forming segment extending from afirst end of the second loop forming segment at the first end of thefirst coil along the outside of the second coil to the first end of thesecond coil, and extending through the interior of the second coil tothe second end of the second coil at a second end of the second loopforming segment, the first portion of the first section extending awayfrom the second end of the second loop forming segment, the second loopfarming segment holding the second coil in a looped configuration withthe first end of the second coil adjacent to the second end of thesecond coil.
 19. The apparatus of claim 17, wherein the coil includesbetween 20 and 200 turns.
 20. The apparatus of claim 18, wherein thefirst coil includes between 20 and 200 turns and the second coilincludes between 20 and 200 turns 21-28. (canceled)